NITE - Chemical Management Field

Latest GHS Classification Results by the Japanese Government (edited by NITE)

GENERAL INFORMATION

Item	Information
CAS RN	80-43-3
Chemical Name	2-Phenyl-2-[(2-phenylpropan-2-yl)peroxy]propane
Substance ID	m-nite-80-43-3_v2
Download of Excel format	Excel file

REFERENCE INFORMATION

Item	Information
Guidance used for the classification (External link)	To Guidance List
UN GHS document (External link)	To UN GHS document
FAQ（GHS classification results by the Japanese Government）	To FAQ
List of Information Sources (Excel file)	List of Information Sources
List of Definitions/Abbreviations	Definitions/Abbreviations
Sample Label by MHLW (External link)	MHLW Website (in Japanese Only)
Sample SDS by MHLW (External link)	MHLW Website (in Japanese Only)
OECD/eChemPortal (External link)	To OECD/eChemPortal (External link)

PHYSICAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Explosives	Not classified	- -	-	-	Although the peroxide group is included in chemical structure, since the calculation value of oxygen balance was -266 it was classified into Not classified.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Flammable gases	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Aerosols	Not classified (Not applicable)	- -	-	-	Not aerosol products	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Oxidizing gases	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Gases under pressure	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Flammable liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Flammable solids	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
8	Self-reactive substances and mixtures	Not classified (Not applicable)	- -	-	-	Organic peroxide	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Pyrophoric liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Pyrophoric solids	Not classified	- -	-	-	Even if it contacts the normal temperature air, it does not ignite spontaneously (ignition point 380degC (IUCLID,2000)).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
11	Self-heating substances and mixtures	Classification not possible	- -	-	-	The test method applicable for substances becoming liquid or gas at 140degC of test temperature has not been established.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
12	Substances and mixtures which, in contact with water, emit flammable gases	Not classified (Not applicable)	- -	-	-	Metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At) are not included.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
13	Oxidizing liquids	Not classified (Not applicable)	- -	-	-	Solid	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
14	Oxidizing solids	Classification not possible	- -	-	-	Although it is an organic compound having peroxy group in the molecule, classification is not possible due to lack of data.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
15	Organic peroxides	Type F	Warning	H242	P370+P378 P210 P234 P235 P240 P280 P403 P410 P411 P420 P501	It was classified into Class 5.2 in the United Nations Recommendations on the Transport of Dangerous Goods (UN No.3110(ICSC, 1999).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
16	Corrosive to metals	Classification not possible	- -	-	-	Test methods applicable to solid substances are not available.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
17	Desensitized explosives	-	- -	-	-	-	-	-

HEALTH HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
1	Acute toxicity (Oral)	Not classified	- -	-	-	From LD50 value >2,000 mg/kg (Health, Labor and Welfare Ministry report (Access on September 2008)) of the acute oral toxicity test (OECD TG 401, GLP) employing a rat, it was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Dermal)	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Gases)	Not classified (Not applicable)	- -	-	-	Since it was a solid by the definition of GHS and inhalation in gas was not assumed, it was classified into "Not applicable".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Vapours)	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
1	Acute toxicity (Inhalation: Dusts and mists)	Classification not possible	- -	-	-	Since it is a solid, a dust standard is applied. Since 6-hour LCLo value of rats is >0.09 mg/L (4-hour equivalent >0.14 mg/L) (DFGOT vol.3 (1992), Patty (5th, 2001)), the classification cannot be specified, and classification is not possible.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
2	Skin corrosion/irritation	Not classified	- -	-	-	For patch tests in human, there have been descriptions of "slight" irritation (DFGOT vol.3 (1992)) and "slight" irritation in the patch test to 200 volunteers (Patty (5th, 2001)). Moreover, for rats, although there has been a description of "mild" irritation (Patty (5th, 2001)), and it seems to be equivalent to skin irritation Category 3 in the U.N. GHS, it was classified into "Not classified" with unemployed catergory in the country. It can be classified as Xi in the EU classification; R36/ 38 (EU-Annex I).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
3	Serious eye damage/eye irritation	Category 2B	- Warning	H320	P305+P351+P338 P337+P313 P264	From the description of "mild "eye irritation (DFGOT vol.3 (1992)) of "Mild conjunctivitis was produced in drop of 50% solution."(Patty (5th, 2001)) to rabbits, it was classified into Category 2B. In addition, EU classification is Xi; R36/38 (EU-Annex I).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Respiratory sensitization	Classification not possible	- -	-	-	Classification is not possible since there is no data.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
4	Skin sensitization	Not classified	- -	-	-	For humans, it has been described that "it showed a slight irritation not skin sensitization in the patch test to 200 volunteers" (Patty (5th, 2001)). Moreover, there is a description of "no sensitizing potential" in the intracutaneous injection tests employing guinea pig with unknown numbers (Patty (5th, 2001)). Therefore, it was classified into "Not classified".	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
5	Germ cell mutagenicity	Classification not possible	- -	-	-	In the in vitro mutagenicity test (the mutagenicity test employing bacteria (OECD TG 471, GLP) and chromosome aberration test employing Chinese hamster culture cells (CHL/IU) (OECD TG 473, GLP)) both are "negative" (Health, Labor and Welfare Ministry reports (Access on September 2008)), classification is not possible because there is no data of in vivo examination.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
6	Carcinogenicity	Classification not possible	- -	-	-	Since no evaluation by major international evaluation agencies is made, classification is not possible. There is no data in the source of information of List1. In addition, HSDB (2002) has a description that "as the comparison of tumor promoting activities of various organic peroxides made by the mouse dermal administration test, this article's activity is in the medium degree."	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
7	Reproductive toxicity	Category 1B	Danger	H360	P308+P313 P201 P202 P280 P405 P501	[Rationale for the Classification] Based on (1) to (3), the view of the RAC of the ECHA (Committee for Risk Assessment of the European Chemical Agency) was supported, and this substance was classified in Category 1B. It was classified based on the new information source. [Evidence Data] (1) In a developmental toxicity study with female rats dosed by gavage (days 5 to 19 of gestation), an increase in post-implantation embryonic/fetal death, lower fetal weight, and increases in the incidences of external malformations (mal-rotated fore- and hindlimbs) and skeletal malformations (short and/or bent scapula, clavicula, humerus, radius, and ulna) were observed in a group treated with a high dose (450 mg/kg/day) at which death (1/24 animals), clinical signs (such as salivation, piloerection), and decreases in food consumption and body weight gain were observed in dams. It was reported that, also in a group treated with a middle dose (150 mg/kg/day), salivation, and decreases in food consumption and body weight gain were observed in dams, and skeletal malformations (short and/or bent scapula) were observed in fetuses (CLH Report (2014), ECHA RAC (Background Doc.) (2015), REACH registration dossier (Accessed Oct. 2021)). (2) It was reported that the Committee for Risk Assessment of the European Chemical Agency (ECHA RAC) studied the status of fetal death from dams on an individual basis in a high-dose group in (1), and as a result, a total of 20/65 intrauterine deaths were observed in 5 dams with no abnormalities in clinical signs or necropsy findings, which suggested that post-implantation loss and increased intrauterine mortality were not necessarily related to maternal toxicity (ECHA RAC (2015)). (3) Based on the results in (1), the proposers proposed a reproduction classification of Category 2 for this substance, but the RAC of the ECHA expressed the view that Repr. 1B was appropriate, emphasizing an increase in intrauterine death and increased skeletal malformations based on (2) and (1) in which skeletal malformations were observed from the middle dose at which maternal toxicity was not severe (ECHA RAC (2015)). [Reference Data, etc.] (4) In a screening assessment in Canada, LOAEL/NOAEL was judged to be 450/150 mg/kg/day both for maternal toxicity and developmental effects on fetuses because, based on (1), an increase in post-implantation loss, and increased skeletal malformations were observed in fetuses in a group treated with the highest dose (450 mg/kg/day) at which maternal toxicity was apparent (Canada CMP Screening Assessment (2019)). (5) In the EU CLP classification (Accessed Oct. 2021), it was classified as Repr. 1B.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
8	Specific target organ toxicity - Single exposure	Category 3 (Respiratory tract irritation)	Warning	H335	P304+P340 P403+P233 P261 P271 P312 P405 P501	There is a description of "The symptoms were observed to tend to recover 1st day after administration and all of them recovered by 6th day." in the oral single administration test employing rats (Health, Labor and Welfare Ministry reports (Access on September 2008)). On the other hand, since there is a description of "It irritates a respiratory tract." in the paragraph of the effects of short term exposure of ICSC (1999), it classified into Category 3 (Respiratory tract irritation). In addition, although there is a description of "Slight inflammation occurred in nasal mucosas within 1 hour after exposure" in dropping test to rabbit's nostril (Patty (5th, 2001)), since it is the effect by non-standard test method, it is not adopted.	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
9	Specific target organ toxicity - Repeated exposure	Category 1 (nasal mucosa)	Danger	H372	P260 P264 P270 P314 P501	For humans, "changes in the nasal mucosa" are reported as effects of exposure to this substance in 18 workers (DFGOT vol. 3 (1992), Patty (5th, 2001)). For animals, in 28-day repetition oral administration test using rats (Guideline for 28-Day Repeated oral administration Toxicity Test in Mammalian Species (Chemical Substances Control Law of Japan), GLP), although there is a description of "Hypertrophy and denaturation of hepatic cell" (Health, Labor and Welfare Ministry reports (Access on September 2008)), there is no description about the details of denaturation. From description of "metaplasia of nasal mucosas and loss of cilia (DFGOT vol.3 (1992)), in the repeated inhalation exposure test employing guinea pig, the effect on the nose membrane to the was seen within the range of the guidance value of Category 1 and the effect on liver was seen out of the range of the guidance value of Category 2. As mentioned above, it was classified into Category 1 (nasal mucosas).	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）
10	Aspiration hazard	Classification not possible	- -	-	-	Classification not possible due to lack of data	FY2008	GHS Classification Guidance by the Japanese Government （Sep, 2008）

ENVIRONMENTAL HAZARDS

Hazard class		Classification	Pictogram Signal word	Hazard statement (code)	Precautionary statement (code)	Rationale for the classification	Classification year (FY)	GHS Classification Guidance for the Japanese Government
11	Hazardous to the aquatic environment Short term (Acute)	Category 1	Warning	H400	P273 P391 P501	It was classified in Category 1 from 48-hour EC50 = 0.262 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1999), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2011)).	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
11	Hazardous to the aquatic environment Long term (Chronic)	Category 1	Warning	H410	P273 P391 P501	If chronic toxicity data are used, then it is classified in Category 2 due to being not rapidly degradable (a degradation rate by BOD: 0% (Biodegradation and Bioconcentration Results of Existing Chemical Substances under the Chemical Substances Control Law, METI, 1984)) and 21-day NOEC = 0.117 mg/L for crustacea (Daphnia magna) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1999), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2011), EU REACH CoRAP, 2014, SIAP, 2012). If acute toxicity data are used for a trophic level for which chronic toxicity data are not obtained (fish), then it is classified in Category 1 due to being not rapidly degradable and 96-hour LC50 = 0.469 mg/L for fish (Oryzias latipes) (Results of Aquatic Toxicity Tests of Chemicals conducted by Ministry of the Environment in Japan (Ministry of the Environment, 1999), Environmental Risk Assessment for Chemical Substances (Ministry of the Environment, 2011)). By drawing a comparison between the above results, it was classified in Category 1.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))
12	Hazardous to the ozone layer	Classification not possible	- -	-	-	This substance is not listed in the Annexes to the Montreal Protocol.	FY2021	GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0))

NOTE:

GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

To GHS Information